NCT00004810已完成2 期
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
National Center for Research Resources (NCRR)0 个研究点目标入组 30 人开始时间: 1996年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
OBJECTIVES:
I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
详细描述
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.
Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.
Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •Mildly to moderately severe ulcerative colitis
- •Patient age: 18 to 80
排除标准
- 未提供
研究者
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